Nelson Laboratories, LLC – FDA 483, Jul 30, 2025

Between July 14 and July 30, 2025, the FDA inspected Nelson Laboratories, LLC, a testing facility in Salt Lake City, Utah. The inspection revealed significant deficiencies in the firm’s quality program and its adherence to Current Good Tissue Practices (CGTP) for handling human cells, tissues, and tissue-based products (HCT/Ps). A primary concern involved persistent environmental contamination; the facility failed to eradicate Bacillus cereus from its cleanrooms over several months, and investigators observed technicians using poor sterile techniques, such as dropping bone samples onto work surfaces. Furthermore, the laboratory demonstrated a lack of testing integrity by amending positive bioburden and sterility results to negative without sufficient scientific justification when organisms could not be recovered for identification. Additional violations included a loss of traceability between test results and specific donor lots, inadequate procedures for handling diverse tissue types, and a failure to properly isolate or label materials that failed sterilization cycles. Personnel also lacked the necessary tissue-specific training to perform their duties safely. While these observations do not constitute a final agency determination, Nelson Laboratories is expected to respond with a comprehensive corrective action plan to address these systemic failures in contamination control, documentation, and testing accuracy.